ANI and SPI Guided Intraoperative Analgesia

University Hospital Hradec Kralove

Status: Completed

Conditions: Anesthesia

Treatments: Drug: Sufentanil ANI analgesia; Drug: Sufentanil anesthesiologist analgesia; Drug: Sufentanil SPI analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT02490540

201506S 38P

Details and patient eligibility

About

There is accumulating evidence that inappropriate analgesia is asssociated with increasing risk of perioperative complications. The aim of the study is to compare intraoperative analgesia guided according to different methods of intraoperative analgesia monitoring, ANI and SPI respectively.

Full description

The Surgical Pleth Index (SPI) and ANI (Analgesia Nociception Index) has been developed for monitoring of adequacy of analgesia during surgery.

The investigators want to compare anesthesiologist guided intraoperative analgesia with intraoperative analgesia guieded by ANI or SPI.

The following hypotheses have been made:

1. Anesthesiologist guided analgesia will result in lower surgical stress
2. Anesthesiologist guided analgesia will result in more hemodynamic stability and faster recovery of the patient after anesthesia

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing scheduled neurosurgical procedures under general anesthesia
• GCS 15
• ASA physical status I - III
• elective procedures with estimated duration 1 - 3 hours

Exclusion criteria

• Presence of non-sinus rhythm
• pacemaker
• planned postoperative ventilation
• procedures with planned awake intervals
• chronic pain with opioid medication
• opioid addiction
• epidural administration of local anaesthetic in combination with opioid
• corticosteroid use
• hormonal contraception
• chronic respiratory disease with known respiratory failure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 3 patient groups

Anesthesiologist quided analgesia

Experimental group

Description:

Sufentanil anesthesiologist analgesia is based on anesthesiologist decision.

Treatment:

Drug: Sufentanil anesthesiologist analgesia

ANI guided analgesia

Experimental group

Description:

Sufentanil ANI analgesia based on ANI analgesia monitor figures.

Treatment:

Drug: Sufentanil ANI analgesia

SPI guided analgesia

Experimental group

Description:

Sufentanil SPI analgesia is based on the SPI analgesia monitor figures.

Treatment:

Drug: Sufentanil SPI analgesia